Pharmacyclics to submit NDA for Xcytrin to treat lung cancer with brain metastases

By E. Janene Geiss

Philadelphia, May 9 - Pharmacyclics, Inc. announced Tuesday that the company plans to submit a New Drug Application to the Food and Drug Administration to market Xcytrin (motexafin gadolinium) injection for the treatment of non-small cell lung cancer patients with brain metastases.

The company also announced that new analyses and additional data from its phase 3 Smart trial will be presented at the upcoming annual meeting of the American Society of Clinical Oncology in Atlanta, according to a company news release.

The Smart trial was conducted at 94 centers in North America, Europe and Australia and enrolled 554 patients with brain metastases from non-small cell lung cancer.

This randomized, controlled phase 3 trial compared the safety and efficacy of whole brain radiation therapy alone to radiation plus Xcytrin. The primary endpoint was time to neurologic progression as determined by a blinded events review committee, officials said.

Pharmacyclics is developing Xcytrin as an anticancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce programmed cell death.

Xcytrin has been granted fast-track designation by the FDA for use in the treatment of lung cancer brain metastases.

Pharmacyclics is a Sunnyvale, Calif., pharmaceutical company developing products to treat cancer, atherosclerosis and other serious diseases.

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